在高级ALK阳性NSCLC中Ficonalkib (SY-3505):一个多中心,开放标签,单臂,1/2期研究
Yuankai Shi1, Xingsheng Hu1, Xingya Li2
1Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, the People's Republic of China.
概括
第三代ALK TKI的Ficonalkib (SY-3505) 显示出有前途的疗效和有利的安全性概况,适用于耐第二代ALK TKI的ALK阳性高级非小细胞肺癌患者.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 对于患有ALK阳性晚期非小细胞肺癌 (NSCLC) 的患者,他们对第二代ALK氨酸激酶抑制剂 (TKIs) 耐药,存在有限的治疗选择.
- 第三代ALK TKI代表了这种患者群体的潜在治疗进步.
研究的目的:
- 为了评估ficonalkib (SY-3505) 的安全性,药理动力学和疗效,它是一种新型的第三代ALK TKI.
- 为了确定先进的ALK阳性NSCLC患者的推二期剂量 (RP2D) 的ficonalkib.
主要方法:
- 进行了首次在人身上进行的1/2期临床试验,包括剂量升级和剂量扩展阶段.
- 患者每天口服一次 (QD) 接受ficonalkib.
- 主要终点包括第一阶段的安全性和第二阶段的客观反应率 (ORR).
主要成果:
- 菲康纳基布被很好地吸收和耐受,600毫克QD被确定为RP2D.
- 在600毫克QD用ficonalkib治疗的患者中,整体ORR为47.5%,包括在脑转移患者中,内ORR为37.5%.
- 与治疗相关的不良事件在90.9%的患者中观察到,其中14.8%的患者经历了3级或更高的事件.
结论:
- 菲科纳尔基布在ALK阳性NSCLC患者中表现出良好的安全性和有前途的疗效,这些患者对之前的第二代ALK TKIs有抗性.
- 菲科纳尔基布代表了这个具有挑战性的患者群体的潜在新治疗选择.
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